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Not yet recruiting NCT07717762

Building a Swiss Pain Registry: A National Framework for Acute and Chronic Pain Assessment

Observational Chronic Pain Acute Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Pain, Acute Pain. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this observational registry is to systematically collect and analyse real-world clinical and patient-reported data in individuals receiving treatment for acute and chronic pain. The main questions it aims to answer are: How do pain intensity, functional status, and quality of life evolve over time in patients with acute and chronic pain? How are different routine clinical treatment approaches associated with patient-reported outcomes in real-world clinical practice? Participants already receiving standard care for pain management will have routine clinical data recorded as part of their treatment and will be asked to complete standardized questionnaires on pain intensity, functional status, and quality of life at multiple time points during treatment and follow-up. Data are collected using a secure electronic system and are pseudonymised prior to analysis in accordance with Swiss data protection regulations.

Detailed description

This prospective, observational registry study aims to establish a standardized, multidomain digital assessment platform for patients with acute and chronic pain within routine outpatient care at the University Hospital Bern. The registry is designed as a scalable national infrastructure with planned expansion to additional Swiss pain clinics. The primary objective is to evaluate feasibility, acceptability, and data quality of a digital baseline assessment integrating validated patient-reported outcome measures (PROMs) across pain, functional, psychological, sleep, and quality-of-life domains. Secondary objectives include the description of baseline patient profiles, exploration of longitudinal outcomes at 6, 12, 18, and 24 months, assessment of operational feasibility of follow-up assessments, and investigation of sex- and gender-related differences. In addition, optional treatment-triggered follow-up modules may be used after therapeutic interventions to capture short-term outcomes, side effects, and patient-reported treatment satisfaction. Data are collected prospectively via REDCap and include both routinely documented clinical data and additional patient-reported outcomes. The study duration is 36 months, including a 12-month recruitment phase and 24 months of follow-up per participant.

Primary outcome measures

  • Feasibility of baseline assessment [Time frame: Baseline (at enrollment)]
  • Data quality of baseline assessment [Time frame: Baseline (at enrollment)]
Secondary outcome measures (12)
  • Pain intensity [Time frame: Baseline, 6, 12, 18, 24 months]
  • Pain interference [Time frame: Baseline, 6, 12, 18, 24 months]
  • Neuropathic pain screening [Time frame: Baseline, 6, 12, 18, 24 months]
  • Neuropathic pain symptom profile [Time frame: Baseline, 6, 12, 18, 24 months]
  • Functional disability [Time frame: Baseline, 6, 12, 18, 24 months]
  • Work ability [Time frame: Baseline, 6, 12, 18, 24 months]
  • Psychological distress [Time frame: Baseline, 6, 12, 18, 24 months]
  • Pain catastrophizing [Time frame: Baseline, 6, 12, 18, 24 months]
  • Sleep quality [Time frame: Baseline, 6, 12, 18, 24 months]
  • Health-related quality of life [Time frame: Baseline, 6, 12, 18, 24 months]
  • Global patient-reported improvement [Time frame: 6, 12, 18, 24 months]
  • Follow-up completion and adherence [Time frame: 6, 12, 18, 24 months]

Eligibility criteria

Inclusion criteria

  • Signed informed consent by the participant or legal guardian for minors.
  • Diagnosis of acute or chronic pain (chronic pain defined as pain lasting ≥ 3 months), including nociceptive, neuropathic, or mixed pain conditions.
  • Referral for interdisciplinary outpatient pain assessment or treatment.
  • Sufficient proficiency in German, French, Italian, or English to complete digital assessments (parental proxy allowed for paediatric participants if needed).
  • All age groups included.

Exclusion criteria

  • Lack of capacity to provide informed consent or absence of a legal guardian for minors.
  • Inability to understand study languages and complete assessments even with assistance.
  • Acute life-threatening conditions precluding participation.
  • Site-specific safety considerations as determined by treating clinician.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Switzerland · 1 center
  • Universitätsklinik für Anästhesiologie und Schmerzmedizin, Inselspital, Universitätsspital — Bern

Identifiers

NCT: NCT07717762 · 2026-00636

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗